Initiation Clinical Research Associate Ii

2+ years

Not Disclosed

Bangalore

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate (CRA)
Company: Parexel
Location: [Insert Location]

About Parexel:
As a Clinical Research Associate (CRA) at Parexel, you are a key player in getting treatments to patients more quickly. Our CRAs prioritize patient safety and well-being while traveling to investigator sites and performing monitoring duties. We encourage our team members to be inquisitive, accountable, and build strong relationships while acting with integrity. Join us to work on global projects across various therapeutic areas and grow both personally and professionally in a dynamic and collaborative environment.

About This Role:
As a CRA at Parexel, you will manage the entire lifecycle of clinical trial monitoring, from site identification to closeout. You will serve as a primary point of contact for assigned sites, ensuring the smooth initiation, implementation, and completion of clinical studies. You will be responsible for building relationships with investigators, ensuring compliance with regulatory standards, and addressing site-specific issues. Your role will require independent judgment, problem-solving skills, and the ability to work with cross-functional teams to ensure project success.

Key Accountabilities:

Start-up Phase (from site identification through pre-initiation):

Act as Parexel's direct contact with assigned sites during the start-up phase.
Build strong relationships with investigators and site staff.
Conduct country-specific feasibility and site pre-qualification and qualification activities, including facilitating the execution of Confidentiality Agreements (CDA) and Clinical Site Agreements (CSAs).
Conduct remote Qualification Visits (QVs) and generate visit reports to address site issues and implement resolutions.
Develop strategies for configuring, collecting, and reviewing essential regulatory documents (SRP), ensuring they meet country-specific and regulatory requirements.
Manage IRB/IEC and MoH/RA submissions, ensuring appropriate follow-up until approval.
Submit relevant documentation to the trial master file (TMF) as per sponsor and company policies.
Forecast and manage plans for site activation, patient recruitment, and retention.
Use Clinical Trial Management Systems (CTMS) to maintain up-to-date project data and resolve any site issues proactively.

Maintenance Phase (from initiation through close-out):

Continue to be the primary point of contact for assigned sites, ensuring adherence to study protocols.
Address and resolve site-specific issues, including deficiencies in training, documentation, and communication.
Monitor data quality and integrity, taking appropriate follow-up actions as necessary.
Actively participate in Investigator meetings, audits, and regulatory inspections.
Evaluate site recruitment plans and collaborate with site staff to improve patient recruitment strategies.
Conduct on-site visits, including Qualification and Initiation visits, and manage remote visits as needed.
Perform regular assessments of site compliance, performance, and staff capabilities, offering recommendations for improvements.

Overall Accountabilities (from Site Identification to Closeout):

Ensure timely and accurate completion of project goals and update applicable trial management systems.
Work closely with team members to ensure efficient project planning and goal completion.
Ensure that assigned sites are audit and inspection-ready at all times.
Maintain compliance with ICH-GCP guidelines, international/local regulations, and Parexel SOPs.
Support administrative tasks and provide feedback on team performance.
Demonstrate commitment to high-quality work and maintain a positive, collaborative environment.

Skills & Qualifications:

Excellent problem-solving and judgment skills, able to resolve site issues effectively.
Ability to work independently with minimal oversight, taking proactive steps to manage issues.
Strong interpersonal skills and ability to build relationships with investigators, site staff, and team members.
Strong analytical skills with the ability to prioritize tasks and meet deadlines.
Knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office (Excel, Word).
Ability to travel as required by study needs and project phases.
Attention to detail and the ability to work in a virtual team environment.

Knowledge & Experience:

Previous site management or clinical research experience with a strong understanding of clinical trial methodology and terminology.

Education:

A degree in biological science, pharmacy, or a related health discipline is preferred, or an equivalent nursing qualification or relevant clinical experience.

Why Parexel?
At Parexel, we offer the opportunity to work on cutting-edge clinical research projects while contributing to global healthcare. We foster a culture of professional growth, teamwork, and collaboration to ensure the safety and well-being of patients around the world. If you're looking for an exciting and rewarding career in clinical research, apply today to be part of our global team.

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Initiation Clinical Research Associate Ii

Job Description

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